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Novartis refiles paperwork to FDA for novel cholesterol drug inclisiran

By Brian Buntz | July 6, 2021

Novartis
Novartis (NYSE: NVS) has resubmitted paperwork to the FDA for inclisiran, a subcutaneously-delivered drug candidate for treating hyperlipidemia in adults whose low-density lipoprotein cholesterol (LDL-C) remains elevated after taking a maximum tolerated dose of statin therapy.

In Dec. 2020, FDA issued a complete response letter (CRL) for inclisiran. A CRL indicates that the agency has decided not to approve a new drug application. In this case, FDA had expressed concern over unresolved inspection-related conditions at an Italian contract development and manufacturing organization (CDMO).

In a statement, Novartis announced that it plans to shift inclisiran production to its facility in Schaftenau, Austria. The company said it planned to move production of the drug to that plant before it received the CRL.

In its CRL, FDA did not relay concerns related to the safety or efficacy of inclisiran.

Novartis won EU approval for the drug in December.

RNAi therapeutics specialist Alnylam Pharmaceuticals first developed the drug, which the Medicines Company. Novartis completed the acquisition of the Medicines Company in early 2020.


Filed Under: clinical trials, Drug Discovery, Metabolic disease/endicrinology
Tagged With: CDMO, complete response letter, contract development and manufacturing organization, CRL, FDA, inclisiran, Medicines Company, Novartis
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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